The goal of this clinical trial is to learn if the drug Alpha1H works to treat low-to-intermediate risk non-muscle-invasive bladder cancer in adults. It will also learn about the safety of drug Alpha1H.
The main questions it aims to answer are:
* Does giving drug Alpha1H before surgery lower the risk of cancer returning or worsening compared to standard care alone? * Is drug Alpha1H safe and well-tolerated by participants? Researchers will compare participants receiving drug Alpha1H before standard surgery to participants receiving standard care alone to see if drug Alpha1H lowers the risk of cancer returning or progressing.
Participants will:
* Be randomly assigned to receive either drug Alpha1H before surgery or standard care alone. * Receive drug Alpha1H directly into the bladder 6 times over about 1 month if assigned to the Alpha1H group. * Hold the liquid in the bladder for up to 2 hours during each visit. * Undergo standard surgery through the urethra (TURBT) to remove remaining tumor tissue. * Visit the clinic regularly for follow-up checkups (including bladder examinations and urine tests) to check if the cancer returns. * Fill out questionnaires about their quality of life.
Signed and dated informed consent.
Low-risk NMIBC: Primary, solitary, Ta, low-grade, 0.5 cm to 3 cm.
Primary multifocal (<10 lesions), Ta, low-grade, 0.5 cm to 3 cm;
Recurrent solitary, Ta, low-grade, 0.5 cm to 3 cm; or
Patient with non-papillary tumor appearance at the time of initial cystoscopy.
Previous history of T1 or high-grade disease in recurrent tumors.
Patients with T1 or high-grade non-muscle invasive papillary bladder cancer (NMIBC).
Previous intravesical BCG immunotherapy.
Parallel
Alpha1H
DrugAdministered via intravesical instillation directly into the urinary bladder. Participants in the experimental group receive a total of 6 instillations on Days 1, 3, 5, 8, 15, and 22 over approximately 1 month prior to TURBT. During each treatment, participants are asked to retain the solution in the bladder for up to 2 hours.
Transurethral Resection of Bladder Tumor (TURBT)
Procedure/SurgeryStandard endoscopic surgical procedure performed through the urethra to resect and remove papillary bladder tumor tissue. Performed approximately 30 days after study entry (on Visit 8). Resected tumor tissue is collected for histopathology and central analysis.
Intravesical Chemotherapy
DrugA single early intravesical instillation of standard-of-care chemotherapy (epirubicin, mitomycin, or gemcitabine) administered into the urinary bladder shortly following TURBT surgery in accordance with local institutional guidelines.
Event-Free Survival (EFS)
Complete Response (CR) Rate
Overall Survival (OS)
Tumor Response (Morphological and Cellular)
Assessed as: (1) change in papillary tumor size (% reduction from baseline); (2) tumor cell shedding in urine (cells/mL); (3) apoptosis in shed cells (% TUNEL-positive cells); (4) Alpha1H uptake in shed cells (% Alpha1H-positive cells). Each parameter reported separately.
Tumor Gene Expression
Assessed by RNA sequencing (whole transcriptome) in tumor tissue and urine RNA. Reported as number of differentially expressed cancer-related genes and pathways between the Alpha1H and SOC arms.
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